Dynamically controlled treatment protocols for autonomous treatment systems

ABSTRACT

Systems, and methods relate to a medical device receiving a treatment parameter operating point within a first operating region defined by a first set of operating points for which automatic incremental adjustment of a parameter in the current operation is permitted. In an illustrative example, incremental adjustment may use artificial intelligence based on patient feedback and sensor measurement of outcomes. Some exemplary devices may receive a request to alter the current treatment parameter operating point to a second treatment parameter operating point outside the first operating region and in a second operating region in a known safe operation zone, bounded by a known unsafe zone unavailable to the user. In the second operating region, some examples may restrict the step size of incremental adjustments requested by the user. Data may be collected for cloud-based analysis, for example, to facilitate discovery of more effective treatment protocols.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/936,462, titled “DYNAMICALLY CONTROLLED TREATMENT PROTOCOLS FORAUTONOMOUS TREATMENT SYSTEMS,” filed by Douglas, et al. on Nov. 9, 2015,and which claims the benefit of U.S. Provisional Application Ser. No.62/077,500, titled “Dynamically Controlled Treatment Protocols in CloseLoop Autonomous Treatment Systems,” filed by Douglas on Nov. 10, 2014.

This application incorporates the entire contents of the foregoingapplications herein by reference.

TECHNICAL FIELD

Various embodiments relate generally to medical devices, and morespecifically to dynamic treatment protocols for optimizing patientoutcomes.

BACKGROUND

Advances in personal medical care technology have provided devicesuseful for unsupervised individual medical treatment. Medical devicesthat provide therapy on an out-patient, or at-home, basis may supplyimportant healthcare solutions for treating an increasing variety ofconditions.

Some out-patient medical devices provide one or more patient monitoringfunctions. Examples of monitoring functions may include blood pressuremonitors, SpO2 blood oxygen sensors, heart rate monitors, or cardiacsignature (e.g., ECG). In some systems, electrical impedancemeasurements may be made to measure fluid levels, such as for edemameasurements, for example.

Several medical devices for out-patient use offer therapeutic deliverymechanisms, some of which may be combined with monitoring functions.Examples of some therapeutic delivery systems that may be used by on anout-patient basis may include, for example, insulin pumps, wound caretreatment systems, and positive airway pressure systems. Suchtherapeutic medical devices may be programmed to deliver to the patienta treatment protocol as prescribed by a physician.

SUMMARY

Systems, and methods relate to a medical device receiving a treatmentparameter operating point within a first operating region defined by afirst set of operating points for which automatic incremental adjustmentof a parameter in the current operation is permitted. In an illustrativeexample, incremental adjustment may use artificial intelligence based onpatient feedback and sensor measurement of outcomes. Some exemplarydevices may receive a request to alter the current treatment parameteroperating point to a second treatment parameter operating point outsidethe first operating region and in a second operating region in a knownsafe operation zone, bounded by a known unsafe zone unavailable to theuser. In the second operating region, some examples may restrict thestep size of incremental adjustments requested by the user. Data may becollected for cloud-based analysis, for example, to facilitate discoveryof more effective treatment protocols.

Apparatus and associated methods may also relate to sensing the progressand outcomes of medical treatment protocols, interacting with a patientor other users, and automatically adapting treatment protocols foroptimal outcomes in response to sensor data and patient feedback.Treatment parameters, such as pressure, temperature, flow, and durationof treatment, which define a treatment protocol, may be automaticallyvaried within safe or approved limits. Treatment parameters beyond safeor approved limits may be denied. Treatment parameters within a saferegion but outside of a region for automatically optimized treatmentparameter adjustment may be authorized by a patient with consent tocollect and share collected data. In an illustrative example, atreatment system may operate to treat a patient's wound with appliedpressure while monitoring the patient's blood pressure and heart rate,varying the applied pressure and duration of treatment for optimalhealing, while constraining applied pressure and patient heart rate andblood pressure within safe limits.

Various embodiments may achieve one or more advantages. For example,some embodiments may improve efficiency of personal medical treatment byallowing more effective therapy automatically customized to a patient'scondition and tolerance for treatment. In addition, some embodiments mayprovide cost savings by allowing patients to avoid regular travel to aclinic for treatment. Some embodiments may improve patient outcomes byautomatic adjustment of treatment parameters for optimal therapeuticoutcomes. Other embodiments may provide patients with increased autonomyand privacy as they may be able to treat themselves rather thandepending on a health care provider for supervised therapy. In additionto the benefits and advantages to the patient, as already described,some embodiments provide an opportunity for society wide improvements tohealth care therapy, through sensor data and user feedback collected andadded to the global knowledge base, including the added benefit of thepotential for identifying and studying new, more effective medicaltreatment protocols, all while remaining in safe limits.

The details of various embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an exemplary medical care device providing automaticoptimization, according to defined limits, of treatment protocols totreat a patient's wound with applied pressure while monitoring thepatient's blood pressure and heart rate.

FIG. 2 depicts a detail view of an exemplary partitioning of treatmentprotocol operating points into regions including personalized treatment,automatic treatment, patient authorized treatment, and safety limitedzones.

FIG. 3 depicts an operational flow of an exemplary medical care deviceproviding automatic optimization with reference to defined limits of atreatment protocol.

FIG. 4 depicts the structure of an exemplary medical care deviceproviding automatic optimization, according to defined limits, oftreatment protocols.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

To aid understanding, this document is organized as follows. First, theapplication of a medical care device providing automatic optimization oftreatment protocols, according to defined limits and with potentialcollaboration with a doctor, is introduced in with reference to FIG. 1.Second, with reference to FIG. 2, the discussion turns to exemplaryoperational scenarios, for a medical care device providing automaticoptimization, according to defined limits, of treatment protocols, thatillustrate exemplary partitioning of treatment parameter operatingpoints into regions. Specifically, a trajectory of treatment parameteroperating points automatically governed by the device as a function ofsensor data and user feedback is presented. Third, with reference toFIG. 3, a flow of a process for automatically optimizing treatmentparameter operating points, including the decision process invoked todetermine if a regional boundary between treatment parameter operatingpoints can be crossed, is presented. Finally, with reference to FIG. 4,the structure of an exemplary medical care device providing automaticoptimization of treatment protocols, according to defined limits andwith potential collaboration with a doctor, is presented.

FIG. 1 depicts an exemplary medical care device providing automaticoptimization, according to defined limits, of treatment protocols totreat a patient's wound with applied pressure while monitoring thepatient's blood pressure and heart rate. In FIG. 1, a patient 100 iswearing an exemplary compression boot 105 attached to patient's leg 110for treatment of a wound, an exemplary blood pressure measuring cuff 115attached to patient's arm 120 for monitoring of patient's bloodpressure, and an exemplary pulse measurement sensor 125 attached topatient's finger 130 for measurement of patient's heart rate. Thecompression boot, blood pressure measuring cuff, and pulse measurementsensor are operatively connected with and controlled by treatment system135 to automatically adjust treatment parameters for optimal care withinapproved treatment parameter limits. A treatment system defines a set ofparameters that define the treatment protocol as a treatment parameteroperating point. In an illustrative example, a treatment systempartitions the possible treatment parameter operating points intotreatment parameter operating point regions 140, including: region 145designated for automatic adjustment for optimized treatment; region 150designated for approved treatment parameter ranges driven by a patientwith limited increments; and a region circumscribing the region 150 anddesignated as having unsafe treatment parameter values, for example arequest for cuff pressure or treatment duration in excess of a safelimit will not be permitted by a treatment system. In an illustrativeexample, a treatment system may be communicatively coupled via a cloudconnection to a doctor or other health care provider resources.

In an illustrative example, a treatment system may send a requestmessage to a doctor for approval of treatment parameters in varioustreatment parameter operating point regions, and upon receipt of doctorapproval, the treatment system may unlock a broadened set of parameterranges in the next outer ring of treatment parameter operating pointregions. In an illustrative example, a treatment system may allow adoctor at a computer communicatively coupled with a treatment systemthrough a cloud connection to monitor and/or set therapy parameters andupdate limits in a remote or local server, or in a treatment system, orcommunicate with a patient directly such as via email, video chat, textmessage, or other communication capability as would be known to one ofordinary skill in the art.

In an illustrative example, a treatment system may govern a treatmentprotocol for pressure cuff therapy by measuring, monitoring andcontrolling treatment parameters including, for example: peak inflationpressure; inflation ramp rate; deflation rate; duration; duty cycle;frequency of treatment; time of day for treatment; location oftreatment. These and/or other parameters may form a set of parametersthat define the cuff therapy treatment protocol. A particular set ofparameters may be referred to herein as a treatment parameter operatingpoint.

In an illustrative example, a treatment system may govern a treatmentprotocol for insulin pump therapy, by measuring, monitoring andcontrolling treatment parameters including, for example: bolus volume;flow rate; dispensing duration; times of day; and frequency per day, asa set of parameters that define the insulin pump therapy protocol.

In an illustrative example, the FDA may approve a wound treatmentprotocol within a range of effective treatment parameters. A wound caretreatment may be found to promote healing and minimize swelling between1.5 LBS of pressure per inch of treatment area and 3 LBS of pressure perinch of treatment area of pressure. The treatment protocol range maythen be 2.25+/−0.75 LBS of pressure to the effected region, withcorresponding limitations placed on a patient's heart rate and bloodpressure during treatment. In an illustrative example, a treatmentprotocol scenario may begin with treatment parameters includingpressure, heart rate, and blood pressure within an FDA-approvedoperating region, with the compression boot inflated to stimulatecirculation and reduce swelling three times per day, while measuringheart rate, blood pressure. The protocol may include getting feedbackfrom the patient about the effectiveness of the treatment, e.g., if painwas reduced, or numbness became apparent.

Based on feedback sensor data and/or patient feedback, the treatmentparameters may be adapted, by an artificial intelligence (AI)application associated with the treatment system. In someimplementations, the AI application may be partially or wholly executedon the remote or local server or database. The AI application may causethe treatment system 135 to adjust its operating point parameters in anon-going treatment or in future treatments. In an illustrative example,the AI may determine to incrementally increase or decrease the peak cuffcompression pressure. In another example, the AI application maydetermine to incrementally adjust a frequency or interval betweentreatments. The adjustments made by the AI application may be restrictedto predetermined increments, which may be within limits approved by FDA,and/or authorized by a doctor's orders.

In an illustrative example, a treatment system may adjust treatmentparameters to optimize treatment as a function of feedback on patientoutcomes from sensor data measured and analyzed by a treatment system.In an illustrative example, sensor data used by a treatment system forfeedback on patient outcomes may include patient body temperature orapplied treatment temperature, applied treatment pressure, patient heartrate, patient blood oxygen (SPO2) level, or patient blood pressure. Inaddition, sensor data from common exercise or fitness monitors,including wrist worn activity monitors, may be collected for feedback onpatient outcomes. Data from various sensors and input devices may becollected by the treatment system 135, for example. Various data sourcesmay connect to the treatment system 135 via wired or wireless links. Insome implementations, data may be delivered to the remote or localserver, which may receive data collected by the treatment system 135. Insome examples, data may be downloaded from the remote or local server tothe treatment system 135 for processing locally at the patient's site.

In an illustrative example, sensor data representative of patient heartrate, blood oxygen level, and blood pressure may define a treatmentparameter operating point below an optimal treatment parameter operatingpoint for a certain treatment protocol. Based on the sensor data, atreatment parameter, such as an applied treatment temperature orpressure for example, may be increased for optimal therapeutic outcomefor the particular patient, while maintaining heart rate, bloodpressure, and blood oxygen within approved, safe limits.

In an illustrative example, a treatment system may adjust treatmentparameters to optimize treatment as a function of feedback on patientoutcomes from patient survey data obtained by a treatment system. In anillustrative example, a treatment system may poll a user, and collect,and analyze user responses. In an illustrative example, patient surveydata used by a treatment system for feedback on patient outcomes mayinclude: responses to questions from the treatment system such as askinga patient how they feel; rating their pain on scale of 1-10; asking if atreatment protocol or parameter relieved pain, or increased pain; orasking if numbness or tingling increased, decreased, appeared, ordisappeared. In addition, a treatment system may collect and analyzeuser response to questions about patient activities and dailyperformance including the duration and quality of sleep, exerciselevels, food intake, allergies, medications, fluid intake, smoking, andso on. In an illustrative example, in view of a recent intake ofcaffeine as determined by a patient survey, a treatment system may adapttreatment parameters for a treatment protocol by adjusting bloodpressure allowed during treatment.

In an illustrative example, a treatment system may adjust treatmentparameters to optimize treatment as a function of feedback on patientoutcomes from health care provider survey data. In an illustrativeexample, a treatment system may interrogate health care providers,collect, and analyze health care provider response. In an illustrativeexample, health care provider survey data used by a treatment system forfeedback on patient outcomes may include: responses to questions from atreatment system via electronic communication to ask relevant questionsvia electronic communication of nurses, pharmacists, physicians,nutritionists, and so on. In an illustrative example, a treatment systemmay determine from a patient survey that a patient has not taken theirblood pressure medication, and the same treatment system may learn frominquiring of the patient's doctor via electronic communication that inview of these conditions, a safe blood pressure parameter limitationshould be enforced for a scheduled treatment.

FIG. 2 depicts a detail view of an exemplary partitioning of treatmentprotocol operating points into regions including personalized treatment,automatic treatment, patient authorized treatment, and safety limitedzones. In FIG. 2, a partitioning 200 into regions or zones of treatmentparameter operating points is illustrated.

By way of example and not limitation, a treatment parameter operatingpoint may represent a combination of treatment parameters includingpressure, frequency, heart rate, respiration rate, flow rate, treatmentfrequency, treatment schedule, time of treatment, or other measured oreffected treatment parameters known to one of ordinary skill in the art.

A treatment protocol scenario may begin with a treatment parameteroperating point 205 located with treatment parameters personalized orcustomized by a user to values within an approved, safe treatmentparameter operation point region 210 designated for user-customized, orpersonalized, treatment. In some implementations, the treatment systemmay be programmed to give the patient discretion to adjust the operatingpoint to a new treatment parameter operating point 215 that is withinthe region 210. This limited operating region 210 may provide for minor,unsupervised adjustments that deviate from the initial operating pointprescribed by the physician, for example.

In response to feedback including sensor data or user response, atreatment system may automatically adjust treatment parameters withinapproved limits to a new treatment parameter operating point 220, withina region 225 designated for automatic adjustment of treatment parameterswithin approved limits. In an illustrative example, a treatment scenariomay continue with automatic adjustment, under a closed-loop automaticcontrol and/or responsive to an AI engine configured to automaticallyadjust the operating point on a search to find an optimal patientoutcome. In this region 225, the treatment system may automaticallyadjust the operating point in response to sensor monitoring and patientfeedback. Using incremental adjustment of parameters, the treatmentsystem may incrementally move the operating point of parameters along atrajectory within the region 225 to seek a treatment parameter operatingpoint 230 that produces optimal patient health outcomes. Accordingly,the operating point of parameters may be automatically migrated withinthe treatment parameter region 225 approved for automatic treatment. Insome embodiments, the operating point under AI control may migrateanywhere within the regions 210, 225.

In an illustrative example, a treatment scenario may continue withautomatic adjustment in response to monitoring and feedback, and a newtreatment parameter operating point 235 may be automatically selectedwithin the treatment parameter region 225 approved for automatictreatment.

In an illustrative example, a patient may select treatment parameters ata treatment parameter operating point 240 located outside the boundaryof the region 225, and in a region 245 designated for treatmentparameter values requiring boundary authorization. Upon encounteringthis boundary between the regions 225, 245, a treatment evaluation andboundary authorization procedure is invoked. In this example,authorization to cross the boundary from the region 225 into the region245 is not obtained, and treatment remains at the treatment parameteroperating point 235 within the region 225.

The patient may then select treatment parameters at a treatmentparameter operating point 250 located outside the boundary of the region225, and in the region 245 designated for treatment parameter valuesrequiring boundary authorization. In response to this attempt to expandthe treatment protocol operating point into the region 245, a treatmentevaluation and boundary authorization procedure is invoked. Ifauthorization is obtained, such as from a physician, then treatmentcontinues at the new treatment parameter operating point 250.

Within the region 245, the treatment system may govern the maximumincrement or step size of any parameter changes. For example, foroperating points within the region 245, the patient can self-directchanges to the therapy, but may only change parameters between sessionsor within an on-going session within predetermined limits programmed bythe physician and/or device manufacturer. The degree or amplitude of theparameter changes may be limited by a governor function of the device.These limits or parameter governor functions may advantageously protectthe patient from radically altering the therapy in an uncontrolled waythat is very different from recent, familiar operating points. This mayadvantageously protect the patient from receiving an erratic course oftherapies that may reduce the diagnostic value of the feedback onpatient outcomes. In some examples, the treatment system may only permitchanges to one parameter at a time. In some examples, the treatmentsystem may impose minimum dwell times on some operating points, to allowthe patient's body time to respond to an operating point before thepatient is allowed to change that parameter. For example, the treatmentsystem may only allow the patient to increase the duration of a therapyby 5 minutes, with a minimum dwell time of 1 week; accordingly, thetreatment system would not allow the patient to increase the durationagain until the previous increase had been in place for at least 1 week.In some embodiments, the treatment system may not impose a dwell timerequirement to revert to a prior operating point, such as the operatingpoint 235. This may advantageously allow a patient to test a newoperating point, but still prevent unintended stress on the patient whenthe patient instructs the treatment system to rapidly alter a therapy tounfamiliar operating points to which the patient is not accustomed.

In an illustrative example, a patient may select treatment parameters totransition from the operating point 250 to a treatment parameteroperating point 255 located within a region 260. In various embodiments,the maximum safe operating area for therapeutic use of the device may becircumscribed by the outer limit of the region 260.

Parameter configurations that extend outside of the region 260 aredesignated as unsafe for treatment. Such operating points may bedisallowed by hardware and or software of the treatment system. Patientselection of an unsafe treatment parameter operating point isautomatically denied, with treatment continuing at the previoustreatment parameter operating point within any of permissible or saferegions 310, 225, 245, 260. In some embodiments, the treatment systemmay send an electronic message or alert upon a boundary crossing from aninterior region to an exterior region, for example. In some examples, aphysician may be alerted (e.g., by email, SMS text message, phone call)upon an attempt by the patient to expand the treatment protocol range byentering the region 245 or 260. In some examples, the devicemanufacturer may be alerted if the patient attempts to move theoperating point outside of the maximum safe operating area circumscribedby the outer limit of the region 260.

In some embodiments, the treatment system may receive upgrades tosoftware from the remote or local server. The server may update theparameter ranges associated with each of the regions 210, 225, 245, 260,for example, to reflect new knowledge of safe operating regions, bestpractices, and/or optimal treatment protocols. The physician may alterthe shape or size of the region 245, for example, based on new knowledgeabout the specific patient, changes in best protocol practices, or as afunction of the patient's physical age, health status, or preferences,for example.

FIG. 3 depicts an operational flow of an exemplary medical care deviceproviding automatic optimization with reference to defined limits of atreatment protocol. In FIG. 3, a computer-implemented method 300 isdisclosed for automatic treatment parameter operating point adjustmentincluding treatment evaluation and boundary authorization. In a firststage, at step 305, treatment effectiveness is evaluated as a functionof sensor data, expected results from treatment protocols, userfeedback, or historical data. In a second stage, at step 310, a test isperformed to determine if treatment was effective. If the treatment iseffective, at step 315, then treatment continues with the treatmentparameter operation point unchanged, and the method returns to step 305at a later time. If the treatment is not effective, at step 320, then atest is performed to determine if operational treatment parameters arewithin a zone designated for automatic treatment parameter adjustment.An example of such a zone is described with reference to the region 225of FIG. 2.

If operational treatment parameters are within a zone designated forautomatic treatment parameter adjustment, then, at step 325, operationaltreatment parameters are incrementally adjusted within approved limits,and treatment continues with a new treatment parameter operating point,with the method returning to step 305 at a later time.

If operational treatment parameters are not within a zone designated forautomatic treatment parameter adjustment, then, at step 330, a test isperformed to determine if a user has selected new treatment parameters.If a user has not selected new treatment parameters, then treatmentcontinues to step 315 with the treatment parameter operation pointunchanged.

If a user has selected new treatment parameters, then, at step 335, atest is performed to determine if the new parameters are within anapproved range. If the new parameters are within an approved range,then, at step 340, the new parameters are put into effect, and treatmentcontinues with a new treatment parameter operation point, and the methodreturns to step 315.

If the new parameters are not within an approved range, then, at step345, warnings are issued to the user, authorization is requested tocross the treatment parameter operation point boundary to a regionrequiring authorization, and authorization to share user and sensor datais requested. At step 350, a test is performed to determine if a userhas authorized crossing the treatment parameter operation point boundaryto a region requiring authorization, and to share user and sensor data.If the user has authorized crossing the treatment parameter operationpoint boundary to a region requiring authorization, and to share userand sensor data, then, at step 355, data is shared and the newparameters are put into effect at step 340. Upon a determination a userhas not authorized crossing the treatment parameter operation pointboundary to a region requiring authorization, and to share user andsensor data, treatment continues with the treatment parameter operationpoint unchanged at step 315.

FIG. 4 depicts the structure of an exemplary medical care deviceproviding automatic optimization, according to defined limits, oftreatment protocols. As illustrated in FIG. 4, a treatment system 135 ofFIG. 1 includes a controller 400 having a processor 405, a memory 410,software 415, and configuration 420 operative to control treatmentaccording to regions of treatment protocol operating points. Examples ofsuch regions were described with reference to FIG. 2, for example. Thecontroller 400 is operatively coupled via Input/Output System 425 toTreatment Effectors Module 430 which may comprise a plurality of typesand configurations of Treatment Effectors or Sensors 435. In anillustrative example, the Treatment Effectors or Sensors 435 may includeinflatable compression boots or cuffs, blood pressure sensors, pumpssuch as an insulin pump, pulse rate sensors, gas composition sensorssuch as an Oxygen sensor, liquid composition sensors such as a bloodglucose sensor, temperature sensors, or other sensors or effectors knownto one of ordinary skill in the art. In an illustrative example, atreatment system may solicit user response or process or user directionreceived through User Interface 440. In an illustrative example,Communication Interface 445 communicatively couples the treatment systemwith remote resources including servers, databases, doctors, or othercaregivers.

Although various embodiments have been described with reference to theFigures, other embodiments are possible. For example, variousembodiments may improve patient safety, product efficacy, and facilitateFDA approval. In particular, one goal of dynamic treatment control maybe to position a device manufacturer to aggregate clinicallysignificant, anonymous, and/or stratified by user profile data aroundhow a population of patients use a therapeutic medical device. Theaggregated data may facilitate improved, faster, or perhaps real-timeupdating of the standard of care for a specific disease. Some treatmentsmay be analyzed, for example, in real-time. This may dramaticallyimprove the database for effective therapeutic protocols that can beused to provide new insights into effectiveness of treatment protocolusing current approved and/or off-label, patient directed therapiesconducted within safe limits. In some treatments that can be automated,substantially real-time updates may provide the knowledge to update thetreatment protocols in real-time, to shift to the latest standard ofcare, and further personalize treatment based on “as it happens” usersensing and input.

Although existing medical treatment systems can be effective, a user mayneed to carefully follow treatment parameters as instructed by a doctor.Treatment parameters which a user may need to carefully adjust, monitor,or control during the course of treatment may include pressure,temperature, duration of treatment, in addition to recording the outcomeof treatment, for example, whether a treatment seemed to improve thepatient's condition, or if increased pressure or duration helped reduceswelling. Various embodiments may provide an improved treatment systemcapable of sensing the progress and outcomes of treatment protocols,interacting with and interfacing with the patient or other users, andautomatically adapting treatment protocols for optimal patienttherapeutic or health outcomes.

The FDA may not immediately approve any medical device that willdynamically shift the treatment protocol without human intervention,monitoring and approval. However, the goal is to develop systems thatare responsive both to the patient and the current state of the art. Inthis way, the goals of the device manufacturer and the goals of theregulators may not be aligned.

In some embodiments, the systems described herein may be designed toprovide maximum personalized medical treatment while staying within atreatment regime that can be readily verified and validated to meetFDA's regulatory requirements.

The over-arching concept is to provide “controlled flexibility,”allowing the system to dynamically adjust treatment protocols within aspecified, pre-tested, parameter range that is comfortable for theregulators. Use outside the specified ranges, like any off-label use,would be at the discretion of the patient and their chosen medicalprofessional. The system would alert the user they have selectparameters outside the approved treatment protocol. The user would needto knowingly consent to change the treatment outside the approvedprotocol either by making a treatment parameter change or by alteringtheir use of the system, such as frequency or duration of use. If theychoose to do so they would be asked to donate their data for study. Thesystem would monitor their progress, grouping like patients together andmonitoring the effects of the modified treatment protocol. Dataincluding user feedback, sensor data, and treatment outcomes from usertreatment experiences may be collected and aggregated as serverstatistics, and the data collected can be analyzed, depersonalized, andused to educate health care workers, and identify more effectivetreatment protocols.

Once enough data is gathered the results would be presented to the FDA.Approval to widen treatment parameters or alter the intended use of theproduct would be requested of the FDA. If granted, the system would beupdated to include the new treatment protocol or indications for use aspart of the standard of care, thereby broadening the area of controlledflexibility that may be offered to the patient population. If suchapproval was not granted solely on the basis of the data collected, thedata could be used to help design a more traditional study and gainapproval by the FDA to conduct such a study.

Once the treatment protocol “tolerances” are opened, each user who hadpreviously been using the system (prior to update) would be alerted andwould need to opt-in to have their device updated. Once opted-in thepatient would benefit from a greater range of automated treatmentsolutions, but would only receive a new treatment if their individualneeds matched the profile for the newer treatment regime.

In some embodiments, the concept may be achieved by the following steps.

Step 1: Prior to automation, manual clinical trials may be conducted toestablish the efficacious boundaries (tolerance) of the treatmentprotocol. Specifically, for example, the dose and/or treatment may betested to the edges of diminishing effect and/or unacceptableside-effects to establish the boundaries of clinical effectiveness.

Step 2: The FDA may evaluate the treatment protocol in the broadestrange that may have been found to provide clinically significanttreatment results. The FDA may then approve the treatment protocolwithin the range of effective treatment. For example, a wound caredevice may be found to promote healing and minimize swelling between 1.5LBS of pressure per sq. inch of treatment area and 3 LBS of pressure persq. inch of treatment area. The treatment protocol range may then be2.25+/−0.75 LBS of pressure to the effected region.

Step 3: The system may then set the autonomous treatment parameters tomatch the FDA approval. 2.25+/−0.75 LBS per sq. inch of pressure withinthe range of the FDA approved treatment protocol.

Step 4: The system may use a combination of standard of care data,(updated by most recent studies and by patient population use),individual data (sensed and solicited) to adjust individual treatmentprotocols within the allowed treatment protocol.

Step 5: Individual treatment protocol may not be adjusted automaticallybeyond FDA evaluated tolerances.

Step 6: To help ensure compliance and manage risk, if the user movesoutside the established and FDA approved treatment protocol theindividual user may be notified that they are operating the deviceoutside of known clinical applications.

Step 7: When required, control boundaries may be in place that onlyallow the treatment protocol to be modified marginally outside theapproved treatment parameters' zone of operation, and may preventoperation for known unsafe parameters.

Step 8: New treatment protocols may be developed and tested outside ofthe FDA approved treatment protocol. The new treatment protocols may bestill within controlled limits with may require informed consent of theuser.

Step 9: All users who have elected to make their data available forstudy and who may operate outside the FDA approved protocol may bemonitored and their data may be analyzed. If these users experiencedegradation in health or care, then the protocol may be discontinued andmay be made not available to additional users. The treatment algorithmmay then be altered accordingly.

Step 10: If the protocol is determined (measured) to be effective, butoutside the FDA approved treatment protocol, the device manufacturer maybe alerted of a new potential universal treatment protocol.

Step 11: The device manufacturer may internally evaluate the newuniversal treatment protocol per FDA guidance for resubmission ofdevices.

Step 12: If the treatment protocol is found to be within the allowableadjustments to the device treatment protocol without additional FDAapproval, device manufacturer may update the outside boundaries of theautonomous adjusting treatment protocol system. A manual update (e.g.,an update made by a human) may be made to the total treatment toleranceand the system may be permitted to extend a broader treatment protocolto the patient population. Go to step 17.

Step 13: If the new treatment protocol is found to be outside theallowable treatments (without further FDA evaluation) the devicemanufacturer may contact the FDA and may obtain approval to furtherstudy the new treatment protocol. During this time the universaltreatment protocols may not be updated and the same treatmentconstraints for the greater user population may be maintained.

Step 14: Additional studies may be conducted, perhaps by monitoring thepatient population who has knowingly chosen to operate outside the FDAapproved treatment protocols.

Step 15: Once a statistically significant amount of treatmenteffectiveness data is collected, the findings may be submitted to theFDA.

Step 16: If the FDA accepts a finding that the tolerances of theuniversal treatment protocol or changes to the intended use of theproduct are updated with greater flexibility and may be made availableto the entire population through automated (dynamic) updating of thetreatment protocol based on patient need, preference and ultimatelyeffective and quantified treatment.

Step 17: Patients may be alerted that broader treatment protocols or newtreatments are available and may be asked if they wish to opt-in for thenew treatment protocols. If they elect to opt-in the new treatments maybe made available to them. These new treatments may be only utilized ifthe patient profile matches the parameters for these new treatmentprotocols.

Step 18: In cases where the updates to the treatment protocol are toensure patient safety or adjust a treatment protocol with the latestinformation (e.g., narrowing the treatment parameters). A patient'streatment protocols may be altered and some patients may be required toopt-in. If they do not opt-in, the device may not function outside thenew safety parameters and the patient may be asked to contact thecompany or their physician.

Step 19: Once new safety boundaries are in place, the patient mayreceive specific warnings if they attempt to use the device outside theknown safety limits. In some cases the device may not permit use outsidethe specific safety boundaries.

Step 20: New universal treatment protocols and/or broadened indicationsfor use may be made available to the system. Tolerances may be updatedto match the latest treatment. Go to step 4.

In some embodiments, a method of dynamically altering treatment methodsmay be performed by a computer system. For example, a medical device maycommunicate with a cloud based server. In some embodiments, the cloudbased server may act as a SAAS (software as a service) model and/orinterface with remote servers in a license/seat model. A decision enginemay operate remotely in some embodiments. In an exemplary embodiment adecision engine may operate locally (e.g., a decision engine may beincluded in the medical device). A neural network or other machinelearning algorithm may be accessible to the decision engine.

In some embodiments, a medical device may communicate with the cloud viaa wireless interface. In some embodiments, an APP for a mobile devicemay interface with a cloud based server. In an exemplary embodiment theAPP may communicate with the medical device. In this way, the APP couldserve as an intermediary between the cloud based server and the medicaldevice. In an exemplary embodiment, an APP template may be provided tomedical device manufacturers to facilitate dynamic treatment behaviorsfor medical devices that these manufacturers develop.

Some embodiments may be in the form of a method of treatment. In someembodiments, software may facilitate the FDA approval process. In anexemplary embodiment, software may facilitate the physician to remotelyadjust a treatment protocol for a patient. Medical device companies mayuse data from remote users to facilitate development of new treatmentprotocols.

Some aspects of embodiments may be implemented as a computer system. Forexample, various implementations may include digital and/or analogcircuitry, computer hardware, other sensors (e.g., temperature sensors,impedance sensors, pressure sensors), firmware, software, orcombinations thereof. Apparatus elements can be implemented in acomputer program product tangibly embodied in an information carrier,e.g., in a machine-readable storage device, for execution by aprogrammable processor; and methods can be performed by a programmableprocessor executing a program of instructions to perform functions ofvarious embodiments by operating on input data and generating an output.Some embodiments can be implemented advantageously in one or morecomputer programs that are executable on a programmable system includingat least one programmable processor coupled to receive data andinstructions from, and to transmit data and instructions to, a datastorage system, at least one input device, and/or at least one outputdevice. A computer program is a set of instructions that can be used,directly or indirectly, in a computer to perform a certain activity orbring about a certain result. A computer program can be written in anyform of programming language, including compiled or interpretedlanguages, and it can be deployed in any form, including as astand-alone program or as a module, component, subroutine, or other unitsuitable for use in a computing environment.

Suitable processors for the execution of a program of instructionsinclude, by way of example and not limitation, both general and specialpurpose microprocessors, which may include a single processor or one ofmultiple processors of any kind of computer. Generally, a processor willreceive instructions and data from a read-only memory or a random accessmemory or both. The essential elements of a computer are a processor forexecuting instructions and one or more memories for storing instructionsand data. Storage devices suitable for tangibly embodying computerprogram instructions and data include all forms of non-volatile memory,including, by way of example, semiconductor memory devices, such asEPROM, EEPROM, and flash memory devices; magnetic disks, such asinternal hard disks and removable disks; magneto-optical disks; and,CD-ROM and DVD-ROM disks. The processor and the memory can besupplemented by, or incorporated in, ASICs (application-specificintegrated circuits). In some embodiments, the processor and the membercan be supplemented by, or incorporated in hardware programmabledevices, such as FPGAs, for example.

In some implementations, each system may be programmed with the same orsimilar information and/or initialized with substantially identicalinformation stored in volatile and/or non-volatile memory. For example,one data interface may be configured to perform auto configuration, autodownload, and/or auto update functions when coupled to an appropriatehost device, such as a desktop computer or a server.

In some implementations, one or more user-interface features may becustom configured to perform specific functions. An exemplary embodimentmay be implemented in a computer system that includes a graphical userinterface and/or an Internet browser. To provide for interaction with auser, some implementations may be implemented on a computer having adisplay device, such as an LCD (liquid crystal display) monitor fordisplaying information to the user, a keyboard, and a pointing device,such as a mouse or a trackball by which the user can provide input tothe computer. For example, wearable devices, such as augmented realitysystems or other technologies may facilitate input and/or outputoperations between a user and a system.

In various implementations, the system may communicate using suitablecommunication methods, equipment, and techniques. For example, thesystem may communicate with compatible devices (e.g., devices capable oftransferring data to and/or from the system) using point-to-pointcommunication in which a message is transported directly from the sourceto the receiver over a dedicated physical link (e.g., fiber optic link,point-to-point wiring, daisy-chain). The components of the system mayexchange information by any form or medium of analog or digital datacommunication, including packet-based messages on a communicationnetwork. Examples of communication networks include, e.g., a LAN (localarea network), a WAN (wide area network), MAN (metropolitan areanetwork), wireless and/or optical networks, and the computers andnetworks forming the Internet. Other implementations may transportmessages by broadcasting to all or substantially all devices that arecoupled together by a communication network, for example, by usingomni-directional radio frequency (RF) signals. Still otherimplementations may transport messages characterized by highdirectivity, such as RF signals transmitted using directional (i.e.,narrow beam) antennas or infrared signals that may optionally be usedwith focusing optics. Still other implementations are possible usingappropriate interfaces and protocols such as, by way of example and notintended to be limiting, USB 2.0, Firewire, ATA/IDE, RS-232, RS-422,RS-485, 802.11 a/b/g/n/ac, Wi-Fi, LTE, Bluetooth, BLE, ZigBee, Ethernet,IrDA, FDDI (fiber distributed data interface), token-ring networks, ormultiplexing techniques based on frequency, time, or code division. Someimplementations may optionally incorporate features such as errorchecking and correction (ECC) for data integrity, or security measures,such as encryption (e.g., WEP) and password protection.

Apparatus, systems, and methods useful for personal medical care incontexts including home health care are disclosed. Various embodimentsmay be equipped to sense the progress and outcomes of treatmentprotocols, interact with and interface to the patient or other users,and automatically adapt treatment protocols for optimal outcomes, byautomatically varying, with reference to defined limitations, treatmentparameters such as pressure, temperature, length of treatment, ortreatment schedule, in response to monitored sensor data, patientresponse, or doctor authorization. Data may be collected for cloud-basedanalysis or decision, to drive the discovery of more effective treatmentprotocols.

A number of implementations have been described. Nevertheless, it willbe understood that various modification may be made. For example,advantageous results may be achieved if the steps of the disclosedtechniques were performed in a different sequence, or if components ofthe disclosed systems were combined in a different manner, or if thecomponents were supplemented with other components. Accordingly, otherimplementations are contemplated, within the scope of the followingclaims.

What is claimed is:
 1. A therapeutic delivery apparatus comprising: atherapy delivery mechanism operably coupled to a processor and adaptedto deliver a predetermined therapy to a patient according to a treatmentparameter operating point defined by a set of parameters associated withthe delivery of the therapy in response to receiving a command signaltransmitted by the processor; a communication interface configured forcommunicating information about the patient to a remote or local server,the communicated information including information about a result of thetherapy applied to the patient by the therapy delivery mechanism; theprocessor operably coupled to control the therapy delivery mechanismaccording to the treatment parameter operating point, and operablycoupled to the communication interface to generate a message thatincludes the result of the therapy applied to the patient by the therapydelivery mechanism; and, a memory device operably coupled to theprocessor and containing instructions, that when executed by theprocessor, cause the processor to perform operations to dynamicallyadjust the treatment parameter operating point, the operationscomprising: receive a current treatment parameter operating point thatlies within a first predetermined operating region defined by a firstset of operating points for which automatic incremental adjustment of aparameter in the current operation is permitted; receive a request toalter the current treatment parameter operating point to a secondtreatment parameter operating point that lies outside of the firstpredetermined operating region and in a second predetermined operatingregion defined by a second set of operating points for whichauthorization is required, wherein the second predetermined operatingregion lies outside of the first predetermined operating region in aspace of operating points; request authorization to alter the treatmentparameter operating point from the first predetermined operating regionto the second predetermined operating region; if the requestedauthorization is received, then generate a second command signal to thetherapy delivery mechanism for delivering therapy to the patientaccording to the second treatment operating point; and, if the requestedauthorization is denied, then generate a first command signal to thetherapy delivery mechanism for delivering therapy to the patientaccording to the first treatment operating point, wherein in response tothe first command signal being received at the therapy deliverymechanism, the therapy delivery mechanism delivers a first predeterminedtherapy to the patient, the first predetermined therapy being associatedwith the first treatment operating point, wherein in response to thesecond command signal being received at the therapy delivery mechanism,the therapy delivery mechanism delivers a second predetermined therapyto the patient, the second predetermined therapy being associated withthe second treatment operating point.
 2. The apparatus of claim 1,wherein the operations further comprise: generate a message to send tothe remote or local server via the communication interface, said messagecontaining data about at least one of: the therapy applied to thepatient by the therapy delivery mechanism, and the result thereof. 3.The apparatus of claim 1, wherein the communication interface is furtherconfigured for receiving information about a first range of parametersthat define the first predetermined operating region, and for receivinginformation about a second range of parameters that define the secondpredetermined operating region.
 4. The apparatus of claim 1, furthercomprising a user interface coupled to the processor and configured toreceive user input representing user feedback about the result of thetherapy applied to the patient by the therapy delivery mechanism.
 5. Theapparatus of claim 1, wherein the operations further comprise: generatea message to send to the remote or local server via the communicationinterface, said message containing data about sensor measurements anduser input feedback associated with the therapy applied to the patientby the therapy delivery mechanism.
 6. The apparatus of claim 1, whereinthe predetermined therapy comprises insulin therapy, and the therapydelivery mechanism comprises an insulin pump.
 7. The apparatus of claim1, wherein the predetermined therapy comprises wound care treatment. 8.The apparatus of claim 1, wherein the predetermined therapy is positiveairway pressure therapy.
 9. The apparatus of claim 1, wherein theoperations further comprise, while the current operating point is in thefirst predetermined operating region, calculating an incrementallydifferent treatment parameter operating point based on a function of atleast one sensor measurement of the patient and a survey of userresponses, and while the current operating point is in the secondpredetermined operating region, calculating a maximum allowed incrementfor the patient to adjust a parameter of the treatment parameteroperating point.
 10. A therapeutic delivery method comprising: providinga therapy delivery mechanism operably coupled to a processor and adaptedto deliver a therapy to a patient according to a treatment parameteroperating point defined by a set of parameters associated with thedelivery of the therapy in response to receiving a command signaltransmitted by the processor; providing a communication interfaceconfigured for communicating information about the patient to a remoteor local server, the communicated information including informationabout a result of the therapy applied to the patient by the therapydelivery mechanism; providing the processor operably coupled to controlthe therapy delivery mechanism according to the treatment parameteroperating point, and operably coupled to the communication interface togenerate a message that includes the result of the therapy applied tothe patient by the therapy delivery mechanism; and, providing a memorydevice operably coupled to the processor and containing instructions,that when executed by the processor, cause the processor to performoperations to dynamically adjust the treatment parameter operatingpoint, the operations comprising: receive a current treatment parameteroperating point that lies within a first predetermined operating regiondefined by a first set of operating points for which automaticincremental adjustment of a parameter in the current operation ispermitted; receive a request to alter the current treatment parameteroperating point to a second treatment parameter operating point thatlies outside of the first predetermined operating region and in a secondpredetermined operating region defined by a second set of operatingpoints for which authorization is required, wherein the secondpredetermined operating region lies outside of the first predeterminedoperating region in a space of operating points; request authorizationto alter the treatment parameter operating point from the firstpredetermined operating region to the second predetermined operatingregion; if the requested authorization is received, then generate asecond command signal to the therapy delivery mechanism for deliveringtherapy to the patient according to the second treatment operatingpoint; and, if the requested authorization is denied, then generate afirst command signal to the therapy delivery mechanism for deliveringtherapy to the patient according to the first treatment operating point,adapting the therapy delivery mechanism to deliver a first predeterminedtherapy to the patient in response to the first command signal beingreceived at the therapy delivery mechanism, wherein the firstpredetermined therapy is associated with the first treatment operatingpoint, adapting the therapy delivery mechanism to deliver a secondpredetermined therapy to the patient in response to the second commandsignal being received at the therapy delivery mechanism, wherein thesecond predetermined therapy is associated with the first treatmentoperating point.
 11. The method of claim 10, wherein the operationsfurther comprise: generate a message to send to the remote or localserver via the communication interface, said message containing dataabout the therapy applied to the patient by the therapy deliverymechanism.
 12. The method of claim 10, wherein the operations furthercomprise: while the current operating point is in the firstpredetermined operating region, calculate an incrementally differenttreatment parameter operating point based on a function of at least onesensor measurement of the patient and a survey of user responses; andwhile the current operating point is in the second predeterminedoperating region, calculating a maximum allowed increment for thepatient to adjust a parameter of the treatment parameter operatingpoint.
 13. The method of claim 10, wherein the predetermined therapycomprises insulin therapy, and the therapy delivery mechanism comprisesan insulin pump.
 14. The method of claim 10, wherein the predeterminedtherapy comprises wound care treatment.
 15. The method of claim 10,wherein the predetermined therapy is positive airway pressure therapy.16. A therapeutic delivery apparatus comprising: a communicationinterface configured for communicating information about the patient toa remote or local server, the communicated information includinginformation about a result of the therapy applied to the patient by atherapy delivery mechanism operably coupled to a processor, wherein thetherapy delivery mechanism is adapted to deliver a therapy to a patientaccording to a treatment parameter operating point defined by a set ofparameters associated with the delivery of the therapy; the processoroperably configured to control the therapy delivery mechanism accordingto the treatment parameter operating point, and operably coupled to thecommunication interface to generate a message that includes the resultof the therapy applied to the patient by the therapy delivery mechanism;and, a memory device operably coupled to the processor and containinginstructions, that when executed by the processor, cause the processorto perform operations to dynamically adjust the treatment parameteroperating point, the operations comprising: receive a current treatmentparameter operating point that lies within a first predeterminedoperating region defined by a first set of operating points for whichautomatic incremental adjustment of a parameter in the current operationis permitted; receive a request to alter the current treatment parameteroperating point to a second treatment parameter operating point thatlies outside of the first predetermined operating region and in a secondpredetermined operating region defined by a second set of operatingpoints for which authorization is required, wherein the secondpredetermined operating region lies outside of the first predeterminedoperating region in a space of operating points; request authorizationto alter the treatment parameter operating point from the firstpredetermined operating region to the second predetermined operatingregion; and, if the requested authorization is received, then generate asecond command signal to the therapy delivery mechanism for deliveringtherapy to the patient according to the second treatment operatingpoint, wherein in response to the second command signal being receivedat the therapy delivery mechanism, the therapy delivery mechanismdelivers a second therapy to the patient, the second predeterminedtherapy being associated with the second treatment operating point. 17.The apparatus of claim 16, wherein the operations further comprise:generate a message to send to the remote or local server via thecommunication interface, said message containing data about the therapyapplied to the patient by the therapy delivery mechanism.
 18. Theapparatus of claim 16, wherein the predetermined therapy comprisesinsulin therapy, and the therapy delivery mechanism comprises an insulinpump.
 19. The apparatus of claim 16, wherein the predetermined therapycomprises wound care treatment.
 20. The apparatus of claim 16, whereinthe predetermined therapy is positive airway pressure therapy.